The term “sterile barrier system” refers to the minimum packaging that prevents proliferation of microorganisms and sterilizing the product to prepare it when it’s time for use. This is where medical pouch sealers play an important role in ensuring that a medical device is safe and sterilized while it’s not being used.
No matter how strict your process of sterilization and disinfection is, you can still have the risk of contaminating your product. This can happen when your packaging and seal closure system is compromised during shipment and storage and could cause serious danger to the user.
The product may be considered a complete sterile barrier system only when it has passed a complete testing protocol and the manufacturer has applied the final seal. This is the only time that the entire packaging system can be considered compliant as per ISO 11607.
